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The Effects of Mesenchymal Stem Cell Secretome in Lupus Patients

Sponsor
Universitas Sebelas Maret (Other)
Overall Status
Completed
CT.gov ID
NCT05921058
Collaborator
(none)
15
Enrollment
1
Location
2
Arms
7.2
Actual Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This research is a clinical trial of administering mesenchymal stem cell secretome to lupus patients.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

This research is experimental. The study was conducted on 30 SLE patient subjects. the treatment group who got the mesenchymal stem cell secretome on the 1st, 2nd day, 3rd, 4th, 5th, 6th, 7th, 14th, 21st, and 28th days. ESR, hs-CRP, C3, C4, interlukin 6, anti-ds-DNA antibody, MEX SLEDAI score, and assessment of drug side effects before and after therapy were collected. Statistical test with paired difference test with p < 0.05

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This study was divided into two groups, namely, control and treatment. Both received intervention in the form of a 1.5 cc injection on the scheduled dayThis study was divided into two groups, namely, control and treatment. Both received intervention in the form of a 1.5 cc injection on the scheduled day
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Mesenchymal stem cell placebo and secretome using injections that are similar in shape and color
Primary Purpose:
Treatment
Official Title:
The Effects of Mesenchymal Stem Cell Secretome in Lupus Patients
Actual Study Start Date :
Aug 1, 2022
Actual Primary Completion Date :
Dec 30, 2022
Actual Study Completion Date :
Mar 9, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Messenchymal stem cell secretome

The hypoxic mesenchymal stem cell secretome has been developed up to chapter 7, stored at -196 C to -135 C in cryopreservation, and has passed quality tests.

Drug: Secretome
Mesenchymal stem cell secretome obtained from Kalbe Pharma Company
Other Names:
  • Messenchymal stem cell Concitioned Media

    		•
    Placebo Comparator: Placebo

    Nacl 0,9% infusion

    Drug: Placebo
    NaCl 0,9% infusion
    Other Names:
  • NaCl 0,9% infusion

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Lupus Disease activity [Change of Lupus Disease Activity at 1 months]

      The data collected were MEX SLEDAI score (range 0-32) before and after therapy.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Lupus paatients
    Exclusion Criteria:
    • Pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Moewardi General Hospital Surakarta Middle Java Indonesia

    Sponsors and Collaborators

    • Universitas Sebelas Maret

    Investigators

    • Principal Investigator: Nurhasan Agung Prabowo, MD, Universitas Sebelas Maret

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Arief Nurudhin, MD. Ph.D, Universitas Sebelas Maret
    ClinicalTrials.gov Identifier:
    NCT05921058
    Other Study ID Numbers:
    • NAP05
    First Posted:
    Jun 27, 2023
    Last Update Posted:
    Jun 27, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Arief Nurudhin, MD. Ph.D, Universitas Sebelas Maret
    Messenchymal Stem Cell Secretome
    Lupus

    Study Results

    No Results Posted as of Jun 27, 2023